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Investigation of Three Contraceptive Hormone Patches in Regard to Inhibition of Ovulation Following Application Over 3 Treatment Cycles in Healthy, Young Women.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01204190
First Posted: September 17, 2010
Last Update Posted: November 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose

The primary objective of this trial is to examine whether ovulation is suppressed after use of hormone patches containing different dosages of ethinyl estradiol (EE) and gestodene (GSD) for 3 treatment cycles. To this end, the blood levels of endogenous hormones (hormones produced by your body) will be measured and transvaginal ultrasound examinations will be conducted at regular intervals. In addition, the concentrations of the administered hormones EE and GSD in blood will be determined in regular intervals.

With regard to the tolerability of the hormone patches subjects will be asked regularly how they feel and blood pressure, pulse and body weight will be determined. In addition, blood and urine safety examinations will be conducted at defined timepoints.


Condition Intervention Phase
Contraception Drug: Gestodene/EE Patch (BAY86-5016) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multicenter, Open-label, Randomized Study to Evaluate Inhibition of Ovulation During Treatment With Three Transdermal Patch Formulations Containing 0.55 mg Ethinylestradiol (EE) and 2.10 mg Gestodene (GSD) or 0.35 mg EE and 0.67 mg GSD or 0.275 mg EE and 1.05 mg GSD in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Hoogland score to evaluate the inhibition of ovulation [ Time Frame: After 2 months ]

Secondary Outcome Measures:
  • Blood level time course of gonadotropins i.e. follicle stimulating hormone (FSH) and luteinizing formone (LH) as well as steroid hormones estradiol and progesterone [ Time Frame: After 2 months ]
  • Follicle size measured by transvaginal ultrasound examination [ Time Frame: After 2 months ]
  • Pharmacokinetics of ethinyl estradiol (EE), gestodene (GSD) and sex hormone binding globuline (SHBG) [ Time Frame: After 2 months ]

Enrollment: 173
Study Start Date: September 2010
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Gestodene/EE Patch (BAY86-5016)
0.55 mg ethinyl estradiol (EE) + 2.1 mg gestodene (GSD) per patch; 3 treatment cycles; 21 days per treatment cycle, i.e. 3 x 7 days patch-wearing phase and a patch-free interval of 7 days
Experimental: Arm 2 Drug: Gestodene/EE Patch (BAY86-5016)
0.35 mg ethinyl estradiol (EE) + 0.67 mg gestodene (GSD) per patch; 3 treatment cycles; 21 days per treatment cycle, i.e. 3 x 7 days patch-wearing phase and a patch-free interval of 7 days
Experimental: Arm 3 Drug: Gestodene/EE Patch (BAY86-5016)
0.275 mg ethiny estradiol (EE) + 1.05 mg gestodene (GSD) per patch; 3 treatment cycles; 21 days per treatment cycle, i.e. 3 x 7 days patch-wearing phase and a patch-free interval of 7 days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy female volunteers
  • age 18 - 35 years (smoker not older than 30 years, inclusive)
  • ovulatory pre-treatment cycle

Exclusion Criteria:

  • Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous or arterial thromboembolic disease)
  • Regular intake of medication other than Oral Contraception
  • Clinically relevant findings (blood pressure, physical and gynecological examination, laboratory examination)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204190


Locations
Germany
Berlin, Germany, 10115
Netherlands
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01204190     History of Changes
Other Study ID Numbers: 15264
2010-021255-81 ( EudraCT Number )
First Submitted: September 16, 2010
First Posted: September 17, 2010
Last Update Posted: November 4, 2014
Last Verified: November 2014

Keywords provided by Bayer:
Administration
Cutaneous

Additional relevant MeSH terms:
Ethinyl Estradiol
Gestodene
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Progestins